Implantable device for external urinary control

ABSTRACT

The present invention relates to an implantable apparatus for obtaining urinary control and emptying of the urinary bladder. The apparatus operates with a powered member ( 100 ) operating from the outside of the urinary bladder assisted by a support structure to discharge urine from the urinary bladder. A control device ( 200 ) controls the operation of the powered member. The control device further comprises a source of energy for operating the powered member and other energy consuming parts of the apparatus and a control assembly.

FIELD OF INVENTION

The present invention relates to an implantable apparatus for obtainingurinary control and emptying of the urinary bladder, thereby preventingfrom or treating involuntary urinary retention. More particularly, theinvention relates to an implantable apparatus for discharging urine fromthe urinary bladder with a powered member operating from the outside ofthe urinary bladder assisted by a support structure.

BACKGROUND OF INVENTION

Urinary dysfunction commonly caused by spinal cord injuries involvesinvoluntary urinary retention, a condition which associated with urinaryinfections, renal damages or damages to the urinary tract. A commontreatment of urinary retention is continuous or intermittentcatheterization. Besides the inconvenience for the patient, cathetersalways represent a risk of acquiring infections. Alternatively suggestedtherapies include electric stimulation of the urinary bladder forproviding muscle contraction and bladder emptying (see e.g. U.S. Pat.No. 6,393,323). Electric stimulation of the bladder needs considerationto that the urinary sphincter is stimulated to contraction byelectricity and pulsed stimulation will become necessary which, however,may lead to uncontrolled squirts of urine through the urethra. It isobvious that there is a need for devices assisting with urinary bladdervoiding which are efficient, reliable and that provide a high level ofpatient compliance.

DESCRIPTION OF INVENTION

In general terms, the present invention relates to an apparatus fortreating urinary retention of a mammal patient, comprising animplantable powered member adapted exert a force from the outside on asselected part of the urinary bladder in order to discharge urine fromthe urinary bladder. The apparatus further comprises a control devicefor controlling the operation of the powered member. The force of thepowered member is exerted at least partly against a support structurewhich is adapted to support against at least one of a bone, such as thepelvic bone, pubic hone or sacrum or spinal cord, other human tissuesuch as peritoneum, the abdominal or pelvic wall or the urine bladderitself.

The control device preferably comprises a source of energy for operatingthe powered member and other energy consuming parts of the apparatus.Arrangements for energizing and controlling the apparatus in the contextof a system comprising the apparatus will be disclosed below. Thecontrol device preferably is adapted to be implanted at least partlysubcutaneously or in the abdomen or in the pelvic region. The controldevice comprises a control assembly adapted to be implanted bothsubcutaneously and/or in the abdominal cavity, said control assemblycomprising at least two parts adapted to be connected, when implanted.

In order to actuate the urinary bladder from the outside, the poweredmember comprises a contacting part adapted to contact a surface part ofthe urinary bladder. The powered member comprises at least one operablepressurizer connected to the contacting part in an arrangement, whereinoperating the pressurizer provides compression or release of the urinarybladder. For this purpose, the powered member can be hydraulically ormechanically operated to provide compression or release of the urinarybladder.

In one embodiment, the pressurizer comprises at least one movable armextending from an operation device to the contacting part of the poweredmember. The operation device is adapted to displace the movable armtowards the urinary bladder in order to discharge urine from the urinarybladder. The operation device is fixated to human tissue, preferably inthis embodiment, to the pubic bone. Further in this embodiment, theoperation device comprises a motor, preferably an electric motor adaptedto displace the movable arm. The contacting part is adapted be fixatedto the upper part of urinary bladder and the contacting part preferablyis designed to extend radially from a point essentially in line with theurinary bladder apex.

In another embodiment the pressurizer comprises a reservoir forhydraulic fluid, and the contacting part comprises an expandable cavityhydraulically connected to the reservoir. The pressurizer comprises apump for transporting the hydraulic fluid from the reservoir to expandthe expandable cavity thereby compressing the urinary bladder. Further,the pressurizer is adapted to have the hydraulic fluid transported fromthe expandable cavity to the reservoir by the urinary pressure in theurinary bladder, when the pump is not active. In order to accomplishtransportation back from the cavity to the reservoir, an arrangement canbe provided wherein a second connection between the expandable cavityand the reservoir adapted to admit transportation hydraulic fluid fromthe expandable cavity to the reservoir by the urinary pressure in theurinary bladder, when the pump is not active. Preferably, the flowcapacity of the second connection is smaller than the pump flow,allowing said second connection to stand open. Alternatively to thisarrangement, the pump can transport hydraulic fluid from the expandablecavity to the reservoir in order to release the urinary bladder.

In still another embodiment, the operable pressurizer comprises anoperation device attached to a support device adapted to be fixated tothe urinary bladder wall. The operable pressurizer comprises an actuatoroperably connected to the operation device comprising a motor to performan actuating movement to actuate the contacting part to compress theurinary bladder. Preferably, the operation device comprises a pivot foraccomplishing a pivotal movement of actuator. The support device isgenerally ring-shaped or having an intermittent ring-shape and extendsalong the periphery of the urinary bladder.

The apparatus as embodied in previous sections further can comprise adevice for electrically stimulating the muscles of the urinary bladderto contract. Such a stimulating device can comprise a plurality ofelectrode strips attached to the muscles of the urinary bladder.

The apparatus as embodied in previous sections can also comprise animplantable pair of restriction devices, wherein the control devicecontrols the restriction devices adapted to close the ureters whendischarging urine from the urinary bladder.

The apparatus as embodied in previous sections can also comprise anartificial urinary sphincter, wherein a restriction device, controlledby the control device performs as a urinary sphincter.

The apparatus as embodied in previous sections can also comprise asensor for measuring any parameter related to the urinary pressure orvolume of the urinary bladder. The sensor is capable of sending a signalto the control device, which thereby activates and deactivates thepowered member.

The present invention also relates to a method of implanting thedisclosed apparatus that comprises the steps of inserting a needle-liketube into the abdomen of the patient; filling the abdomen with gasthrough said tube, thereby expanding the abdominal cavity; placing atleast two laparoscopic trocars in the patient's body and inserting acamera through one of said trocars into the abdomen; inserting at leastone dissecting tool through a trocar and dissecting an area of at leastone portion of the urinary bladder of patient; fixating a first part ofthe powered member to the urinary bladder; fixating another, differentpart of the powered member to human tissue and implanting the controldevice connected to the powered member. In the method the first part ofthe powered member is a contacting part contacting a surface part of theurinary bladder and the different part of the powered member is fixed tothe pubic bone, or the abdominal wall, or the urinary bladder wall. Whenfixating the different part to the urinary wall it is preferred totunneling by suturing the urinary bladder wall to itself in order toimmobilize the different part, while the urinary wall includes or notincludes the peritoneum. Preferably, the different part comprisesgenerally ring shaped support device which preferably extends alongperiphery of the urinary bladder.

The present invention further relates to an alternative method forimplanting the apparatus, comprises the steps of cutting the skin;dissecting an area of at least one portion of the urinary bladder ofpatient; fixating a first part of the powered member to the urinarybladder; fixating another, different part of the powered member to humantissue and implanting the control device connected to the poweredmember. In the method the first part of the powered member is acontacting part contacting a surface part of the urinary bladder and thedifferent part of the powered member is fixed to the pubic bone, or theabdominal wall, or the urinary bladder wall; placing a control deviceoutside the urinary bladder. The method further may include at least oneof the following steps of placing a power source within the body, forpowering the control device;

placing a hydraulic reservoir and placing a pump within the body, forpumping fluid between the reservoir and the expandable member todischarge urine from the urine bladder.

The present invention further relates to system comprising a previousembodies apparatus according to any of claims.

In a preferred embodiment the system comprises at least one switchimplantable in the patient for manually and non-invasively controllingthe apparatus.

In another preferred embodiment, the system comprises a wireless remotecontrol for non-invasively controlling the apparatus.

In a preferred embodiment, the system comprises a hydraulic operationdevice for operating the apparatus.

In one embodiment, the system comprises comprising a motor or a pump foroperating the apparatus.

Further details of the systems applicable with the apparatus asgenerally described herein are outlined below in the detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention will now be described in more detail by way ofnon-limiting examples and with reference to the accompanying drawings,in which:

FIG. 1 shows a schematic crossectional view of an embodiment of theapparatus of invention when implanted in a patient.

FIGS. 2 and 3 schematically show an embodiment of the apparatus with afirst variant of the powered member.

FIGS. 4, 5 and 5A to C schematically show respectively differentembodiments of the pressurizer of the powered member.

FIG. 6 illustrates a system including an apparatus for treating urinaryincontinence according to invention as generally described orillustrated in FIGS. 1 to 5 here in a general form.

FIGS. 7-21 schematically show various embodiments of the system forwirelessly powering the apparatus shown in FIG. 1.

FIG. 22 is a schematic block diagram illustrating an arrangement forsupplying an accurate amount of energy used for the operation of theapparatus shown in FIG. 1.

FIG. 23 schematically shows an embodiment of the system, in which theapparatus is operated with wire bound energy.

FIG. 24 is a more detailed block diagram of an arrangement forcontrolling the transmission of wireless energy used for the operationof the apparatus shown in FIG. 1.

FIG. 25 is a circuit for the arrangement shown in FIG. 19, according toa possible implementation example.

FIGS. 26-32 c show various ways of arranging hydraulic or pneumaticpowering of an apparatus implanted in a patient.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

FIG. 1 is a general crossectional view of the apparatus when implantedin a human patient. Referring to FIG. 2 an embodiment of the apparatusis shown as implanted when operating on a urinary bladder 300. Theapparatus includes a powered member 100 and a control device 200. Thecontrols device 200 controls the operation of the powered member and iscapable of receiving a signal from a sensor 150 related to the volume inthe urine bladder such as a pressure sensor or any sensor related to thewall of the urine bladder (not shown and to communicate out from thebody an alarm signal. The sensor is connected to sensor control unit 205of the control device 200. Several different types of input sensors maybe used determining for example stretching or bending or pressure in theurine bladder wall or for example sensing volume or pressure inside theurine bladder. Most likely these sensors is only indirect causing thebladder to be emptied by presenting an alarm for the patient informingthat it is time to empty the bladder. Such an alarm may be generatedaudible or visually. A remote control 300 controlled from outside bodyof the patient in order to operate the powered member, such as awireless remote control communicating with an internal control unit 203or at least one implanted switch 204. The control device 200 alsoincludes an energy source 201 for supplying energy consuming parts ofthe powered member with energy. The energy source can be wirelesslysupplied from the outside from an energizer unit 400. For this purposethe control device is provided with an energy transforming device 202.The control device comprises an external part 200A which is provided amanually operated switch 201 A and with an injection port 201B forhydraulic fluids communicating with an internal reservoir 206. Thecontrol device further includes a motor/pump function. It iscontemplated that the features related to hydraulic fluid is relevantfor a hydraulic embodiment of FIG. 4 and the powered member 100 includesa pressurizer 140 and a urinary bladder contact part 120 which may befixated to the urinary bladder. The pressurizer includes an operationdevice 144 fixated to human tissue in this case the pubic bone and isoperative connected to movable arm 142 connected to the contacting part.In operation to exert a pressure on the urinary bladder and therebydischarging urine through the urethra, the operation device 144 isactivated by control device to move the arm towards the urinary bladderwhich thereby is contracted. Further FIG. 2 shows a restriction device59B for temporarily restriction of a ureter (this embodiment doses bothureters with restriction devices). The apparatus may eventually beprovided with such restriction devices for the ureters which arecontrolled by the control device 200 to close the ureters when operatingthe powered member to discharge urine in order to prevent from a urinaryflow from the bladder to the kidneys. In operation the control device200 is activated and supplies the powered member with energy. Thepressurizer will then actuate the urinary bladder to compress so theurinary pressure in the bladder is raise so urine is discharges throughthe urethra. When the urinary discharge is finalized the pressurizeralleviates the urinary and returns to its initial position, while therestriction devices for the ureters are released and the urinary bladdercan receive urine from the kidneys. FIG. 3 shows the same apparatus asFIG. 2 when discharging urine through urethra. For this purpose theurinary sphincter 59C is deactivated an open and the restriction device59B. The apparatus needs to exert a considerable pressure (about 60-80cm water pressure) to force urine out from the bladder and urine maythereby backflow through ureters 32A, 32B with potential risks fordamaging the kidneys. To prevent from any such complications, thecontrol device is provided with restriction devices 59A, 59B arranged totemporarily contract the ureters and close them during the operation ofdischarging urine. The urine pressure in the ureter is normally around50 cm water, however short term pressure increase is most likely notdamaging the kidneys and therefore the restriction devices 59A and 59Bmay be omitted.

FIG. 4 shows schematically a variant of the pressurizer which nowincludes reservoir 440 that is hydraulically connected to a cavity 420of the contacting part. A control device 200 controls the operation ofthe pressurizer in a similar way as explained with FIG. 2. Whenoperating the apparatus to discharge urine the control device activatestransportation of fluid from the reservoir 440 to the cavity 420 of thecontacting part which thereby expands in volume so the urinary bladdercompresses and urine is discharge through the urethra as a consequenceof a raised urinary pressure in the bladder. In order to release thebladder, fluid is transported back to the reservoir from the cavity. Theback transportation can either be performed by a powered operation (i.e.a pump operatively connected to the reservoir) or as result of theraising urinary pressure in the bladder. A second connection 444 betweenthe cavity and the reservoir is used for the later transport. If thepump pumping capacity is larger than the flow capacity of said secondconnection the second connection may be opened all the time. FIG. 4further sows a sensor 445 communicating with control device sensorcontrol unit. FIG. 5 shows schematically another variant of thepressurizer 540 including an operation device 544 attached to a supportdevice 510 fixated to the urinary bladder wall. The pressurizer may beboth hydraulically or mechanically operated. In this case a mechanicalconstruction has an actuator 542 operably connected to the operationdevice to perform an actuating movement to actuate the contacting part520 to compress the urinary bladder. In operation to discharge urine,the operation device performs a pivotal movement of the actuator so itcontacts the contact part 520 to compress the urinary bladder in orderto discharge urine through the urethra. When releasing the bladder theoperation device removes the actuator 542 from the contacting part 520to its initial position and the urinary bladder is ready to receiveurine through the ureters.

FIG. 5a shows an embodiment of the apparatus of FIG. 2 with theoperation device 544A placed on the abdominal wall as an alternativesupport function. FIG. 5b shows another alternative of the apparatus ofFIG. 2 with the operation device supported another bone structure. FIG.5c shows an alternative of the apparatus of FIG. 2 without restrictiondevices for the ureters and without a urinary sphincter function.

Some patients having urinary retention also have urinary incontinence.In such a case a separate urinary sphincter 59C is included in thesystem, a restriction device closing the urethra until the patient wantsto urinate. In such a case lower pressure is needed to empty the bladderbecause the no force would be needed to open the sphincter by intrabladder pressure. In this case the ureter restriction devices may beomitted.

The reservoir may be placed anywhere inside the body, however preferablein the abdominal cavity, maybe placed onto the urine bladder or in thepelvic region. The amount of liquid in the reservoir may be calibratedwith fluid by using an injection port placed inside the body withinreach from a special injection port needle. The reservoir may also beomitted and only the injection port may be used to fill and empty theexpandable member.

FIG. 6 illustrates a system for treating urinary retention with anapparatus 10 of the present invention schematically shown placed in theabdomen of a patient. The apparatus 10 can be any of those discussed inthe context of FIGS. 1-5 or as generally described in previous sectionof the description. An implanted energy-transforming device 1002 isadapted to supply energy consuming components of the apparatus withenergy via a power supply line 1003. An external energy-transmissiondevice 1004 for non-invasively energizing the apparatus 10 transmitsenergy by at least one wireless energy signal. The implantedenergy-transforming device 1002 transforms energy from the wirelessenergy signal into electric energy which is supplied via the powersupply line 1003.

The wireless energy signal may include a wave signal selected from thefollowing: a sound wave signal, an ultrasound wave signal, anelectromagnetic wave signal, an infrared light signal, a visible lightsignal, an ultra violet light signal, a laser light signal, a micro wavesignal, a radio wave signal, an x-ray radiation signal and a gammaradiation signal. Alternatively, the wireless energy signal may includean electric or magnetic field, or a combined electric and magneticfield.

The wireless energy-transmission device 1004 may transmit a carriersignal for carrying the wireless energy signal. Such a carrier signalmay include digital, analogue or a combination of digital and analoguesignals. In this case, the wireless energy signal includes an analogueor a digital signal, or a combination of an analogue and digital signal.

Generally speaking, the energy-transforming device 1002 is provided fortransforming wireless energy of a first form transmitted by theenergy-transmission device 1004 into energy of a second form, whichtypically is different from the energy of the first form. The implantedapparatus 10 is operable in response to the energy of the second form.The energy-transforming device 1002 may directly power the apparatuswith the second form energy, as the energy-transforming device 1002transforms the first form energy transmitted by the energy-transmissiondevice 1004 into the second form energy. The system may further includean implantable accumulator, wherein the second form energy is used atleast partly to charge the accumulator.

Alternatively, the wireless energy transmitted by theenergy-transmission device 1004 may be used to directly power theapparatus, as the wireless energy is being transmitted by theenergy-transmission device 1004. Where the system comprises an operationdevice for operating the apparatus, as will be described below, thewireless energy transmitted by the energy-transmission device 1004 maybe used to directly power the operation device to create kinetic energyfor the operation of the apparatus.

The wireless energy of the first form may comprise sound waves and theenergy-transforming device 1002 may include a piezo-electric element fortransforming the sound waves into electric energy. The energy of thesecond form may comprise electric energy in the form of a direct currentor pulsating direct current, or a combination of a direct current andpulsating direct current, or an alternating current or a combination ofa direct and alternating current. Normally, the apparatus compriseselectric components that are energized with electrical energy. Otherimplantable electric components of the system may be at least onevoltage level guard or at least one constant current guard connectedwith the electric components of the apparatus.

Optionally, one of the energy of the first form and the energy of thesecond form may comprise magnetic energy, kinetic energy, sound energy,chemical energy, radiant energy, electromagnetic energy, photo energy,nuclear energy or thermal energy. Preferably, one of the energy of thefirst form and the energy of the second form is non-magnetic,non-kinetic, non-chemical, non-sonic, non-nuclear or non-thermal.

The energy-transmission device may be controlled from outside thepatient's body to release electromagnetic wireless energy, and thereleased electromagnetic wireless energy is used for operating theapparatus. Alternatively, the energy-transmission device is controlledfrom outside the patient's body to release non-magnetic wireless energy,and the released non-magnetic wireless energy is used for operating theapparatus.

The external energy-transmission device 1004 also includes a wirelessremote control having an external signal transmitter for transmitting awireless control signal for non-invasively controlling the apparatus.The control signal is received by an implanted signal receiver which maybe incorporated in the implanted energy-transforming device 1002 or beseparate there from.

The wireless control signal may include a frequency, amplitude, or phasemodulated signal or a combination thereof. Alternatively, the wirelesscontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal. Alternatively, thewireless control signal comprises an electric or magnetic field, or acombined electric and magnetic field.

The wireless remote control may transmit a carrier signal for carryingthe wireless control signal. Such a carrier signal may include digital,analogue or a combination of digital and analogue signals. Where thecontrol signal includes an analogue or a digital signal, or acombination of an analogue and digital signal, the wireless remotecontrol preferably transmits an electromagnetic carrier wave signal forcarrying the digital or analogue control signals.

FIG. 7 illustrates the system of FIG. 6 in the form of a moregeneralized block diagram showing the apparatus 10, theenergy-transforming device 1002 powering the apparatus 10 via powersupply line 1003, and the external energy-transmission device 1004. Thepatient's skin 1005, generally shown by a vertical line, separates theinterior of the patient to the right of the line from the exterior tothe left of the line.

FIG. 8 shows an embodiment of the invention identical to that of FIG. 7,except that a reversing device in the form of an electric switch 1006operable for example by polarized energy also is implanted in thepatient for reversing the apparatus 10. When the switch is operated bypolarized energy the wireless remote control of the externalenergy-transmission device 1004 transmits a wireless signal that carriespolarized energy and the implanted energy-transforming device 1002transforms the wireless polarized energy into a polarized current foroperating the electric switch 1006. When the polarity of the current isshifted by the implanted energy-transforming device 1002 the electricswitch 1006 reverses the function performed by the apparatus 10.

FIG. 9 shows an embodiment of the invention identical to that of FIG. 7,except that an operation device 1007 implanted in the patient foroperating the apparatus 10 is provided between the implantedenergy-transforming device 1002 and the apparatus 10. This operationdevice can be in the form of a motor 1007, such as an electricservomotor. The motor 1007 is powered with energy from the implantedenergy-transforming device 1002, as the remote control of the externalenergy-transmission device 1004 transmits a wireless signal to thereceiver of the implanted energy-transforming device 1002.

FIG. 10 shows an embodiment of the invention identical to that of FIG.7, except that it also comprises an operation device is in the form ofan assembly 1008 including a motor/pump unit 1009 and a fluid reservoir1010 is implanted in the patient. In this case the apparatus 10 ishydraulically operated, i.e. hydraulic fluid is pumped by the motor/pumpunit 1009 from the fluid reservoir 1010 through a conduit 1011 to theapparatus 10 to operate the apparatus, and hydraulic fluid is pumped bythe motor/pump unit 1009 back from the apparatus 10 to the fluidreservoir 1010 to return the apparatus to a starting position. Theimplanted energy-transforming device 1002 transforms wireless energyinto a current, for example a polarized current, for powering themotor/pump unit 1009 via an electric power supply line 1012.

Instead of a hydraulically operated apparatus 10, it is also envisagedthat the operation device comprises a pneumatic operation device. Inthis case, the hydraulic fluid can be pressurized air to be used forregulation and the fluid reservoir is replaced by an air chamber.

In all of these embodiments the energy-transforming device 1002 mayinclude a rechargeable accumulator like a battery or a capacitor to becharged by the wireless energy and supplies energy for any energyconsuming part of the system.

As an alternative, the wireless remote control described above may bereplaced by manual control of any implanted part to make contact with bythe patient's hand most likely indirect, for example a press buttonplaced under the skin.

FIG. 11 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, in this case hydraulically operated, and the implantedenergy-transforming device 1002, and further comprising a hydraulicfluid reservoir 1013, a motor/pump unit 1009 and an reversing device inthe form of a hydraulic valve shifting device 1014, all implanted in thepatient. Of course the hydraulic operation could easily be performed byjust changing the pumping direction and the hydraulic valve maytherefore be omitted. The remote control may be a device separated fromthe external energy-transmission device or included in the same. Themotor of the motor/pump unit 1009 is an electric motor. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the implanted energy-transformingdevice 1002 powers the motor/pump unit 1009 with energy from the energycarried by the control whereby the motor/pump unit 1009 distributeshydraulic fluid between the hydraulic fluid reservoir 1013 and theapparatus 10. The remote control of the external energy-transmissiondevice 1004 controls the hydraulic valve shifting device 1014 to shiftthe hydraulic fluid flow direction between one direction in which thefluid is pumped by the motor/pump unit 1009 from the hydraulic fluidreservoir 1013 to the apparatus 10 to operate the apparatus, and anotheropposite direction in which the fluid is pumped by the motor/pump unit1009 back from the apparatus 10 to the hydraulic fluid reservoir 1013 toreturn the apparatus to a starting position.

FIG. 12 shows an embodiment of the invention comprising the externalenergy-transmission device 1004 with its wireless remote control, theapparatus 10, the implanted energy-transforming device 1002, animplanted internal control unit 1015 controlled by the wireless remotecontrol of the external energy-transmission device 1004, an implantedaccumulator 1016 and an implanted capacitor 1017. The internal controlunit 1015 arranges storage of electric, energy received from theimplanted energy-transforming device 1002 in the accumulator 1016, whichsupplies energy to the apparatus 10. In response to a control signalfrom the wireless remote control of the external energy-transmissiondevice 1004, the internal control unit 1015 either releases electricenergy from the accumulator 1016 and transfers the released energy viapower lines 1018 and 1019, or directly transfers electric energy fromthe implanted energy-transforming, device 1002 via a power line 1020,the capacitor 1017, which stabilizes the electric current, a power line1021 and the power line 1019, for the operation of the apparatus 10.

The internal control unit is preferably programmable from outside thepatient's body. In a preferred embodiment, the internal control unit isprogrammed to regulate the apparatus 10 according to a pre-programmedtime-schedule or to input from any sensor sensing any possible physicalparameter of the patient or any functional parameter of the system.

In accordance with an alternative, the capacitor 1017 in the embodimentof FIG. 12 may be omitted. In accordance with another alternative, theaccumulator 1016 in this embodiment may be omitted.

FIG. 13 shows an embodiment of the invention identical to that of FIG.7, except that a battery 1022 for supplying energy for the operation ofthe apparatus 10 and an electric switch 1023 for switching the operationof the apparatus 10 also are implanted in the patient. The electricswitch 1023 may be controlled by the remote control and may also beoperated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the battery 1022 is notin use, to an on mode, in which the battery 1022 supplies energy for theoperation of the apparatus 10.

FIG. 14 shows an embodiment of the invention identical to that of FIG.13 except that an internal control unit 1015 controllable by thewireless remote control of the external energy-transmission device 1004also is implanted in the patient. In this case, the electric switch 1023is operated by the energy supplied by the implanted energy-transformingdevice 1002 to switch from an off mode, in which the wireless remotecontrol is prevented from controlling the internal control unit 1015 andthe battery is not in use, to a standby mode, in which the remotecontrol is permitted to control the internal control unit 1015 torelease electric energy from the battery 1022 for the operation of theapparatus 10.

FIG. 15 shows an embodiment of the invention identical to that of FIG.14, except that an accumulator 1016 is substituted for the battery 1022and the implanted components are interconnected differently. In thiscase, the accumulator 1016 stores energy from the implantedenergy-transforming device 1002. In response to a control signal fromthe wireless remote control of the external energy-transmission device1004, the internal control unit 1015 controls the electric switch 1023to switch from an off mode, in which the accumulator 1016 is not in use,to an on mode, in which the accumulator 1016 supplies energy for theoperation of the apparatus 10. The accumulator may be combined with orreplaced by a capacitor.

FIG. 16 shows an embodiment of the invention identical to that of FIG.15, except that a battery 1022 also is implanted in the patient and theimplanted components are interconnected differently. In response to acontrol signal from the wireless remote control of the externalenergy-transmission device 1004, the internal control unit 1015 controlsthe accumulator 1016 to deliver energy for operating the electric switch1023 to switch from an off mode, in which the battery 1022 is not inuse, to an on mode, in which the battery 1022 supplies electric energyfor the operation of the apparatus 10.

Alternatively, the electric switch 1023 may be operated by energysupplied by the accumulator 1016 to switch from an off mode, in whichthe wireless remote control is prevented from controlling the battery1022 to supply electric energy and is not in use, to a standby mode, inwhich the wireless remote control is permitted to control the battery1022 to supply electric energy for the operation of the apparatus 10.

It should be understood that the switch 1023 and all other switches inthis application should be interpreted in its broadest embodiment. Thismeans a transistor, MCU, MCPU, ASIC, FPGA or a DA converter or any otherelectronic component or circuit that may switch the power on and off.Preferably the switch is controlled from outside the body, oralternatively by an implanted internal control unit.

FIG. 17 shows an embodiment of the invention identical to that of FIG.13, except that a motor 1007, a mechanical reversing device in the formof a gear box 1024, and an internal control unit 1015 for controllingthe gear box 1024 also are implanted in the patient. The internalcontrol unit 1015 controls the gear box 1024 to reverse the functionperformed by the apparatus 10 (mechanically operated). Even simpler isto switch the direction of the motor electronically. The gear boxinterpreted in its broadest embodiment may stand for a servo arrangementsaving force for the operation device in favour of longer stroke to act.

FIG. 18 shows an embodiment of the invention identical to that of FIG.24 except that the implanted components are interconnected differently.Thus, in this case the internal control unit 1015 is powered by thebattery 1022 when the accumulator 1016, suitably a capacitor, activatesthe electric switch 1023 to switch to an on mode. When the electricswitch 1023 is in its on mode the internal control unit 1015 ispermitted to control the battery 1022 to supply, or not supply, energyfor the operation of the apparatus 10.

FIG. 19 schematically shows conceivable combinations of implantedcomponents of the apparatus for achieving various communication options.Basically, there are the apparatus 10, the internal control unit 1015,motor or pump unit 1009, and the external energy-transmission device1004 including the external wireless remote control. As alreadydescribed above the wireless remote control transmits a control signalwhich is received by the internal control unit 1015, which in turncontrols the various implanted components of the apparatus.

A feedback device, preferably comprising a sensor or measuring device1025, may be implanted in the patient for sensing a physical parameterof the patient. The physical parameter may be at least one selected fromthe group consisting of pressure, volume, diameter, stretching,elongation, extension, movement, bending, elasticity, musclecontraction, nerve impulse, body temperature, blood pressure, bloodflow, heartbeats and breathing. The sensor may sense any of the abovephysical parameters. For example, the sensor may be a pressure ormotility sensor. Alternatively, the sensor 1025 may be arranged to sensea functional parameter. The functional parameter may be correlated tothe transfer of energy for charging an implanted energy source and mayfurther include at least one selected from the group of parametersconsisting of electricity, any electrical parameter, pressure, volume,diameter, stretch, elongation, extension, movement, bending, elasticity,temperature and flow.

The feedback may be sent to the internal control unit or out to anexternal control unit preferably via the internal control unit. Feedbackmay be sent out from the body via the energy transfer system or aseparate communication system with receiver and transmitters.

The internal control unit 1015, or alternatively the external wirelessremote control of the external energy-transmission device 1004, maycontrol the apparatus 10 in response to signals from the sensor 1025. Atransceiver may be combined with the sensor 1025 for sending informationon the sensed physical parameter to the external wireless remotecontrol. The wireless remote control may comprise a signal transmitteror transceiver and the internal control unit 1015 may comprise a signalreceiver or transceiver. Alternatively, the wireless remote control maycomprise a signal receiver or transceiver and the internal control unit1015 may comprise a signal transmitter or transceiver. The abovetransceivers, transmitters and receivers may be used for sendinginformation or data related to the apparatus 10 from inside thepatient's body to the outside thereof.

Where the motor/pump unit 1009 and battery 1022 for powering themotor/pump unit 1009 are implanted, information related to the chargingof the battery 1022 may be fed back. To be more precise, when charging abattery or accumulator with energy feed back information related to saidcharging process is sent and the energy supply is changed accordingly.

FIG. 20 shows an alternative embodiment wherein the apparatus 10 isregulated from outside the patient's body. The system 1000 comprises abattery 1022 connected to the apparatus 10 via a subcutaneous electricswitch 1026. Thus, the regulation of the apparatus 10 is performednon-invasively by manually pressing the subcutaneous switch, whereby theoperation of the apparatus 10 is switched on and off. It will beappreciated that the shown embodiment is a simplification and thatadditional components, such as an internal control unit or any otherpart disclosed in the present application can be added to the system.Two subcutaneous switches may also be used. In the preferred embodimentone implanted switch sends information to the internal control unit toperform a certain predetermined performance and when the patient pressthe switch again the performance is reversed.

FIG. 21 shows an alternative embodiment, wherein the system 1000comprises a hydraulic fluid reservoir 1013 hydraulically connected tothe apparatus. Non-invasive regulation is performed by manually pressingthe hydraulic reservoir connected to the apparatus.

The system may include an external data communicator and an implantableinternal data communicator communicating with the external datacommunicator. The internal communicator feeds data related to theapparatus or the patient to the external data communicator and/or theexternal data communicator feeds data to the internal data communicator.

FIG. 22 schematically illustrates an arrangement of the system that iscapable of sending information from inside the patient's body to theoutside thereof to give feedback information related to at least onefunctional parameter of the apparatus or system, or related to aphysical parameter of the patient, in order to supply an accurate amountof energy to an implanted internal energy receiver 1002 connected toimplanted energy consuming components of the apparatus 10. Such anenergy receiver 1002 may include an energy source and/or anenergy-transforming device. Briefly described, wireless energy istransmitted from an external energy source 1004 a located outside thepatient and is received by the internal energy receiver 1002 locatedinside the patient. The internal energy receiver is adapted to directlyor indirectly supply received energy to the energy consuming componentsof the apparatus 10 via a switch 1026. An energy balance is determinedbetween the energy received by the internal energy receiver 1002 and theenergy used for the apparatus 10, and the transmission of wirelessenergy is then controlled based on the determined energy balance. Theenergy balance thus provides an accurate indication of the correctamount of energy needed, which is sufficient to operate the apparatus 10properly, but without causing undue temperature rise.

In FIG. 22 the patient's skin is indicated by a vertical line 1005.Here, the energy receiver comprises an energy-transforming device 1002located inside the patient, preferably just beneath the patient's skin1005. Generally speaking, the implanted energy-transforming device 1002may be placed in the abdomen, thorax, muscle fascia (e.g. in theabdominal wall), subcutaneously, or at any other suitable location. Theimplanted energy-transforming device 1002 is adapted to receive wirelessenergy E transmitted from the external energy-source 1004 a provided inan external energy-transmission device 1004 located outside thepatient's skin 1005 in the vicinity of the implanted energy-transformingdevice 1002.

As is well known in the art, the wireless energy E may generally betransferred by means of any suitable Transcutaneous Energy Transfer(TET) device, such as a device including a primary coil arranged in theexternal energy source 1004 a and an adjacent secondary coil arranged inthe implanted energy-transforming device 1002. When an electric, currentis fed through the primary coil, energy in the form of a voltage isinduced in the secondary coil which can be used to power the implantedenergy consuming components of the apparatus, e.g. after storing theincoming energy in an implanted energy source, such as a rechargeablebattery or a capacitor. However, the present invention is generally notlimited to any particular energy transfer technique, TET devices orenergy sources, and any kind of wireless energy may be used.

The amount of energy received by the implanted energy receiver may becompared with the energy used by the implanted components of theapparatus. The term “energy used” is then understood to include alsoenergy stored by implanted components of the apparatus. A control deviceincludes an external control unit 1004 b that controls the externalenergy source 1004 a based on the determined energy balance to regulatethe amount of transferred energy. In order to transfer the correctamount of energy, the energy balance and the required amount of energyis determined by means of a determination device including an implantedinternal control unit 1015 connected between the switch 1026 and theapparatus 10. The internal control unit 1015 may thus be arranged toreceive various measurements obtained by suitable sensors or the like,not shown, measuring certain characteristics of the apparatus 10,somehow reflecting the required amount of energy needed for properoperation of the apparatus 10. Moreover, the current condition of thepatient may also be detected by means of suitable measuring devices orsensors, in order to provide parameters reflecting the patient'scondition. Hence, such characteristics and/or parameters may be relatedto the current state of the apparatus 10, such as power consumption,operational mode and temperature, as well as the patient's conditionreflected by parameters such as body temperature, blood pressure,heartbeats and breathing. Other kinds of physical parameters of thepatient and functional parameters of the device are described elsewhere.

Furthermore, an energy source in the form of an accumulator 1016 mayoptionally be connected to the implanted energy-transforming device 1002via the control unit 1015 for accumulating received energy for later useby the apparatus 10. Alternatively or additionally, characteristics ofsuch an accumulator, also reflecting the required amount of energy, maybe measured as well. The accumulator may be replaced by a rechargeablebattery, and the measured characteristics may be related to the currentstate of the battery, any electrical parameter such as energyconsumption voltage, temperature, etc. In order to provide sufficientvoltage and current to the apparatus 10, and also to avoid excessiveheating, it is clearly understood that the battery should be chargedoptimally by receiving a correct amount of energy from the implantedenergy-transforming device 1002, i.e. not too little or too much. Theaccumulator may also be a capacitor with corresponding characteristics.

For example, battery characteristics may be measured on a regular basisto determine the current state of the battery, which then may be storedas state information in a suitable storage means in the internal controlunit 1015. Thus, whenever new measurements are made, the stored batterystate information can be updated accordingly. In this way, the state ofthe battery can be “calibrated” by transferring a correct amount ofenergy, so as to maintain the battery in an optimal condition.

Thus, the internal control unit 1015 of the determination device isadapted to determine the energy balance and/or the currently requiredamount of energy, (either energy per time unit or accumulated energy)based on measurements made by the above-mentioned sensors or measuringdevices of the apparatus 10, or the patient, or an implanted energysource if used, or any combination thereof. The internal control unit1015 is further connected to an internal signal transmitter 1027,arranged to transmit a control signal reflecting the determined requiredamount of energy, to an external signal receiver 1004 c connected to theexternal control unit 1004 b. The amount of energy transmitted from theexternal energy source 1004 a may then be regulated in response to thereceived control signal.

Alternatively, the determination device may include the external controlunit 1004 b. In this alternative, sensor measurements can be transmitteddirectly to the external control unit 1004 b wherein the energy balanceand/or the currently required amount of energy can be determined by theexternal control unit 1004 b, thus integrating the above-describedfunction of the internal control unit 1015 in the external control unit1004 b. In that case, the internal control unit 1015 can be omitted andthe sensor measurements are supplied directly to the internal signaltransmitter 1027 which sends the measurements over to the externalsignal receiver 1004 c and the external control unit 1004 b. The energybalance and the currently required amount of energy can then bedetermined by the external control unit 1004 b based on those sensormeasurements.

Hence, the present solution according to the arrangement of FIG. 22employs the feed back of information indicating the required energy,which is more efficient than previous solutions because it is based onthe actual use of energy that is compared to the received energy, e.g.with respect to the amount of energy, the energy difference, or theenergy receiving rate as compared to the energy rate used by implantedenergy consuming components of the apparatus. The apparatus may use thereceived energy either for consuming or for storing the energy in animplanted energy source or the like. The different parameters discussedabove would thus be used if relevant and needed and then as a tool fordetermining the actual energy balance. However, such parameters may alsobe needed per se for any actions taken internally to specificallyoperate the apparatus.

The internal signal transmitter 1027 and the external signal receiver1004 c may be implemented as separate units using suitable signaltransfer means, such as radio. IR (Infrared) or ultrasonic signals.Alternatively, the internal signal transmitter 1027 and the externalsignal receiver 1004 c may be integrated in the implantedenergy-transforming device 1002 and the external energy source 1004 a,respectively, so as to convey control signals in a reverse directionrelative to the energy transfer, basically using the same transmissiontechnique. The control signals may be modulated with respect tofrequency, phase or amplitude.

Thus, the feedback information may be transferred either by a separatecommunication system including receivers and transmitters or may beintegrated in the energy system. In accordance with the presentinvention, such an integrated information feedback and energy systemcomprises an implantable internal energy receiver for receiving wirelessenergy, the energy receiver having an internal first coil and a firstelectronic circuit connected to the first and an external energytransmitter for transmitting wireless energy, the energy transmitterhaving an external second coil and a second electronic circuit connectedto the second coil. The external second coil of the energy transmittertransmits wireless energy which is received by the first coil of theenergy receiver. This system further comprises a power switch forswitching the connection of the internal first coil to the firstelectronic circuit on and off, such that feedback information related tothe charging of the first coil is received by the external energytransmitter in the form of an impedance variation in the load of theexternal second coil, when the power switch switches the connection ofthe internal first coil to the first electronic circuit on and off. Inimplementing this system in the arrangement of FIG. 17, the switch 1026is either separate and controlled by the internal control unit 1015, orintegrated in the internal control unit 1015. It should be understoodthat the switch 1026 should be interpreted in its broadest embodiment.This means a transistor, MCU, MCPU, ASIC FPGA or a DA converter or anyother electronic component or circuit that may switch the power on andoff.

To conclude, the energy supply arrangement illustrated in FIG. 22 mayoperate basically in the following manner. The energy balance is firstdetermined by the internal control unit 1015 of the determinationdevice. A control signal reflecting the required amount of energy isalso created by the internal control unit 1015, and the control signalis transmitted from the internal signal transmitter 1027 to the externalsignal receiver 1004 c. Alternatively, the energy balance can bedetermined by the external control unit 1004 b instead depending on theimplementation, as mentioned above. In that case, the control signal maycarry measurement results from various sensors. The amount of energyemitted from the external energy source 1004 a can then be regulated bythe external control unit 1004 b, based on the determined energybalance, e,g. in response to the received control signal. This processmay be repeated intermittently at certain intervals during ongoingenergy transfer, or may be executed on a more or less continuous basisduring the energy transfer.

The amount of transferred energy can generally be regulated by adjustingvarious transmission parameters in the external energy source 1004 a,such as voltage, current, amplitude, wave frequency and pulsecharacteristics.

This system may also be used to obtain information about the couplingfactors between the coils in a TET system even to calibrate the systemboth to find an optimal place for the external coil in relation to theinternal coil and to optimize energy transfer. Simply comparing in thiscase the amount of energy transferred with the amount of energyreceived. For example if the external coil is moved the coupling factormay vary and correctly displayed movements could cause the external coilto find the optimal place for energy transfer. Preferably, the externalcoil is adapted to calibrate the amount of transferred energy to achievethe feedback information in the determination device, before thecoupling factor is maximized.

This coupling factor information may also be used as a feedback duringenergy transfer. In such a case, the energy system of the presentinvention comprises an implantable internal energy receiver forreceiving wireless energy, the energy receiver having an internal firstcoil and a first electronic circuit connected to the first coil, and anexternal energy transmitter for transmitting wireless energy, the energytransmitter having an external second coil and a second electroniccircuit connected to the second coil. The external second coil of theenergy transmitter transmits wireless energy which is received by thefirst coil of the energy receiver. This system further comprises afeedback device for communicating out the amount of energy received inthe first coil as a feedback information, and wherein the secondelectronic circuit includes a determination device for receiving thefeedback information and for comparing the amount of transferred energyby the second coil with the feedback information related to the amountof energy received in the first coil to obtain the coupling factorbetween the first and second coils. The energy transmitter may regulatethe transmitted energy in response to the obtained coupling factor.

With reference to FIG. 23, although wireless transfer of energy foroperating the apparatus has been described above to enable non-invasiveoperation, it will be appreciated that the apparatus can be operatedwith wire bound energy as well. Such an example is shown in FIG. 18,wherein an external switch 1026 is interconnected between the externalenergy source 1004 a and an operation device, such as an electric motor1007 operating the apparatus 10. An external control unit 1004 bcontrols the operation of the external switch 1026 to effect properoperation of the apparatus 10.

FIG. 24 illustrates different embodiments for how received energy can besupplied to and used by the apparatus 10. Similar to the example of FIG.17, an internal energy receiver 1002 receives wireless energy E from anexternal energy source 1004 a which is controlled by a transmissioncontrol unit 1004 b. The internal energy receiver 1002 may comprise aconstant voltage circuit, indicated as a dashed box “constant V” in thefigure, for supplying energy at constant voltage to the apparatus 10.The internal energy receiver 1002 may further comprise a constantcurrent circuit, indicated as a dashed box “constant C” in the figure,for supplying energy at constant current to the apparatus 10.

The apparatus 10 comprises an energy consuming part 10 a, which may be amotor, pump, restriction device, or any other medical appliance thatrequires energy for its electrical operation. The apparatus 10 mayfurther comprise an energy storage device 10 b for storing energysupplied from the internal energy receiver 1002. Thus, the suppliedenergy may be directly consumed by the energy consuming part 10 a, orstored by the energy storage device 101), or the supplied energy may bepartly consumed and partly stored. The apparatus 10 may further comprisean energy stabilizing unit 10 c for stabilizing the energy supplied fromthe internal energy receiver 1002. Thus, the energy may be supplied in afluctuating manner such that it may be necessary to stabilize the energybefore consumed or stored.

The energy supplied from the internal energy receiver 1002 may furtherbe accumulated and/or stabilized by a separate energy stabilizing unit1028 located outside the apparatus 10, before being consumed and/orstored by the apparatus 10. Alternatively, the energy stabilizing unit1028 may be integrated in the internal energy receiver 1002. In eithercase, the energy stabilizing unit 1028 may comprise a constant voltagecircuit and/or a constant current circuit.

It should be noted that FIG. 22 and FIG. 24 illustrate some possible butnon-limiting implementation options regarding how the various shownfunctional components and elements can be arranged and connected to eachother. However, the skilled person will readily appreciate that manyvariations and modifications can be made within the scope of the presentinvention.

FIG. 25 schematically shows an energy balance measuring circuit of oneof the proposed designs of the system for controlling transmission ofwireless energy, or energy balance control system. The circuit has anoutput signal centered on 2.5V and proportionally related to the energyimbalance. The derivative of this signal shows if the value goes up anddown and how fast such a change takes place. If the amount of receivedenergy is lower than the energy used by implanted components of theapparatus, more energy is transferred and thus charged into the energysource. The output signal from the circuit is typically feed to an A/Dconverter and converted into as digital format. The digital informationcan then be sent to the external energy-transmission device allowing itto adjust the level of the transmitted energy. Another possibility is tohave a completely analog system that uses comparators comparing theenergy balance level with certain maximum and minimum thresholds sendinginformation to external energy-transmission device if the balance driftsout of the max/min window.

The schematic FIG. 25 shows a circuit implementation for a system thattransfers energy to the implanted energy components of the apparatus ofthe present invention from outside of the patient's body using inductiveenergy transfer. An inductive energy transfer system typically uses anexternal transmitting coil and an internal receiving coil. The receivingcoil, L1, is included in the schematic FIG. 3; the transmitting parts ofthe system are excluded.

The implementation of the general concept of energy balance and the waythe information is transmitted to the external energy transmitter can ofcourse be implemented in numerous different ways. The schematic FIG. 25and the above described method of evaluating and transmitting theinformation should only be regarded as examples of how to implement thecontrol system.

Circuit Details

In FIG. 25 the symbols Y1, Y2, Y3 and so on symbolize test points withinthe circuit. The components in the diagram and their respective valuesare values that work in this particular implementation which of courseis only one of an infinite number of possible design solutions.

Energy to power the circuit is received by the energy receiving coil L1.Energy to implanted components is transmitted in this particular case ata frequency of 25 kHz. The energy balance output signal is present attest point Y1.

Those skilled in the art will realize that the above various embodimentsof the system could be combined in many different ways. For example, theelectric switch 1006 of FIG. 8 could be incorporated in any of theembodiments of FIGS. 11-17 the hydraulic valve shifting device 1014 ofFIG. 11 could be incorporated in the embodiment of FIG. 10, and the gearbox 1024 could be incorporated in the embodiment of FIG. 9. Pleaseobserve that the switch simply could mean any electronic circuit orcomponent.

The embodiments described in connection with FIGS. 22, 24 and 25identify a method and a system for controlling transmission of wirelessenergy to implanted energy consuming components of an electricallyoperable apparatus. Such a method and system will be defined in generalterms in the following.

A method is thus provided for controlling transmission of wirelessenergy supplied to implanted energy consuming components of an apparatusas described above. The wireless energy E is transmitted from anexternal energy source located outside the patient and is received by aninternal energy receiver located inside the patient, the internal energyreceiver being connected to the implanted energy consuming components ofthe apparatus for directly or indirectly supplying received energythereto. An energy balance is determined between the energy received bythe internal energy receiver and the energy used for the apparatus. Thetransmission of wireless energy E from the external energy source isthen controlled based on the determined energy balance.

The wireless energy may be transmitted inductively from a primary coilin the external energy source to a secondary coil in the internal energyreceiver. A change in the energy balance may be detected to control thetransmission of wireless energy based on the detected energy balancechange. A difference may also be detected between energy received by theinternal energy receiver and energy used for the medical device, tocontrol the transmission of wireless energy based on the detected energydifference.

When controlling the energy transmission, the amount of transmittedwireless energy may be decreased if the detected energy balance changeimplies that the energy balance is increasing, or vice versa. Thedecrease/increase of energy transmission may further correspond to adetected change rate.

The amount of transmitted wireless energy may further be decreased ifthe detected energy difference implies that the received energy isgreater than the used energy, or vice versa. The decrease/increase ofenergy transmission may then correspond to the magnitude of the detectedenergy difference.

As mentioned above, the energy used for the medical device may beconsumed to operate the medical device, and/or stored in at least oneenergy storage device of the medical device.

When electrical and/or physical parameters of the medical device and/orphysical parameters of the patient are determined, the energy may betransmitted for consumption and storage according to a transmission rateper time unit which is determined based on said parameters. The totalamount of transmitted energy may also be determined based on saidparameters.

When a difference is detected between the total amount of energyreceived by the internal energy receiver and the total amount ofconsumed and/or stored energy, and the detected difference is related tothe integral over time of at least one measured electrical parameterrelated to said energy balance, the integral may be determined for amonitored voltage and/or current related to the energy balance.

When the derivative is determined over time of a measured electricalparameter related to the amount of consumed and/or stored energy, thederivative may be determined for a monitored voltage and/or currentrelated to the energy balance.

The transmission of wireless energy from the external energy source maybe controlled by applying to the external energy source electricalpulses from a first electric circuit to transmit the wireless energy,the electrical pulses having leading and trailing edges, varying thelengths of first time intervals between successive leading and trailingedges of the electrical pulses and/or the lengths of second timeintervals between successive trailing and leading edges of theelectrical pulses, and transmitting wireless energy, the transmittedenergy generated from the electrical pulses having a varied power, thevarying of the power depending on the lengths of the first and/or secondtime intervals.

In that case, the frequency of the electrical pulses may besubstantially constant when varying the first and/or second timeintervals. When applying electrical pulses, the electrical pulses mayremain unchanged, except for varying the first and/or second timeintervals. The amplitude of the electrical pulses may be substantiallyconstant when varying the first and/or second time intervals. Further,the electrical pulses may be varied by only varying the lengths of firsttime intervals between successive leading and trailing edges of theelectrical pulses.

A train of two or more electrical pulses may be supplied in a row,wherein when applying the train of pulses, the train having a firstelectrical pulse at the start of the pulse train and having a secondelectrical pulse at the end of the pulse train, two or more pulse trainsmay be supplied in a row, wherein the lengths of the second timeintervals between successive trailing edge of the second electricalpulse in a first pulse train and leading edge of the first electricalpulse of a second pulse train are varied.

When applying the electrical pulses, the electrical pulses may have asubstantially constant current and a substantially constant voltage. Theelectrical pulses may also have a substantially constant current and asubstantially constant voltage. Further, the electrical pulses may alsohave a substantially constant frequency. The electrical pulses within apulse train may likewise have a substantially constant frequency.

The circuit formed by the first electric circuit and the external energysource may have a first characteristic time period or first timeconstant, and when effectively varying the transmitted energy, suchfrequency time period may be in the range of the first characteristictime period or time constant or shorter.

A system comprising an apparatus as described above is thus alsoprovided for controlling transmission of wireless energy supplied toimplanted energy consuming components of the apparatus. In its broadestsense, the system comprises a control device for controlling thetransmission of wireless energy from an energy-transmission device, andan implantable internal energy receiver for receiving the transmittedwireless energy, the internal energy receiver being connected toimplantable energy consuming components of the apparatus for directly orindirectly supplying received energy thereto. The system furthercomprises a determination device adapted to determine an energy balancebetween the energy received by the internal energy receiver and theenergy used for the implantable energy consuming components of theapparatus, wherein the control device controls the transmission ofwireless energy from the external energy-transmission device, based onthe energy balance determined by the determination device.

Further, the system may comprise any of the following:

-   -   A primary coil in the external energy source adapted to transmit        the wireless energy inductively to a secondary coil in the        internal energy receiver.    -   The determination device is adapted to detect a change in the        energy balance, and the control device controls the transmission        of wireless energy based on the detected energy balance change.    -   The determination device is adapted to detect a difference        between energy received by the internal energy receiver and        energy used for the implantable energy consuming components of        the apparatus, and the control device controls the transmission        of wireless energy based on the detected energy difference.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy balance change implies that the energy        balance is increasing, or vice versa, wherein the        decrease/increase of energy transmission corresponds to a        detected change rate.    -   The control device controls the external energy-transmission        device to decrease the amount of transmitted wireless energy if        the detected energy difference implies that the received energy        is greater than the used energy, or vice versa, wherein the        decrease/increase of energy transmission corresponds to the        magnitude of said detected energy difference.    -   The energy used for the apparatus is consumed to operate the        apparatus, and/or stored in at least one energy storage device        of the apparatus.    -   Where electrical and/or physical parameters of the apparatus        and/or physical parameters of the patient are determined, the        energy-transmission device transmits the energy for consumption        and storage according to a transmission rate per time unit which        is determined by the determination device based on said        parameters. The determination device also determines the total        amount of transmitted energy based on said parameters.    -   When a difference is detected between the total amount of energy        received by the internal energy receiver and the total amount of        consumed and/or stored energy, and the detected difference is        related to the integral over time of at least one measured        electrical parameter related to the energy balance, the        determination device determines the integral for a monitored        voltage and/or current related to the energy balance.    -   When the derivative is determined over time of a measured        electrical parameter related to the amount of consumed and/or        stored energy, the determination device determines the        derivative for a monitored voltage and/or current related to the        energy balance.    -   The energy-transmission device comprises a coil placed        externally to the human body, and an electric circuit is        provided to power the external coil with electrical pulses to        transmit the wireless energy. The electrical pulses have leading        and trailing edges, and the electric circuit is adapted to vary        first time intervals between successive leading and trailing        edges and/or second time intervals between successive trailing        and leading edges of the electrical pulses to vary the power of        the transmitted wireless energy. As a result, the energy        receiver receiving the transmitted wireless energy has a varied        power.    -   The electric circuit is adapted to deliver the electrical pulses        to remain unchanged except varying the first and/or second time        intervals.    -   The electric circuit has a time constant and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the coil is varied.    -   The electric circuit is adapted to deliver the electrical pulses        to be varied by only varying the lengths of first time intervals        between successive leading and trailing edges of the electrical        pulses.    -   The electric circuit is adapted to supplying a train of two or        more electrical pulses in a row, said train having a first        electrical pulse at the start of the pulse train and having a        second electrical pulse at the end of the pulse train, and    -   the lengths of the second time intervals between successive        trailing edge of the second electrical pulse in a first pulse        train and leading edge of the first electrical pulse of a second        pulse train are varied by the first electronic circuit.    -   The electric circuit is adapted to provide the electrical pulses        as pulses having a substantially constant height and/or        amplitude and/or intensity and/or voltage and/or current and/or        frequency.    -   The electric circuit has a time constant, and is adapted to vary        the first and second time intervals only in the range of the        first time constant, so that when the lengths of the first        and/or second time intervals are varied, the transmitted power        over the first coil are varied.    -   The electric circuit is adapted to provide the electrical pulses        varying the lengths of the first and/or the second time        intervals only within a range that includes the first time        constant or that is located relatively close to the first time        constant, compared to the magnitude of the first time constant.

FIGS. 26-29 show in more detail block diagrams of four different ways ofhydraulically or pneumatically powering an implanted apparatus accordingto the invention.

FIG. 26 shows a system as described above with. The system comprises animplanted apparatus 10 and further a separate regulation reservoir 1013,a one way pump 1009 and an alternate valve 1014.

FIG. 27 shows the apparatus 10 and a fluid reservoir 1013. By moving thewall of the regulation reservoir or changing the size of the same in anyother different way, the adjustment of the apparatus may be performedwithout any valve, just free passage of fluid any time by moving thereservoir wall.

FIG. 28 shows the apparatus 10, a two way pump 1009 and the regulationreservoir 1013.

FIG. 29 shows a block diagram of a reversed servo system with a firstclosed system controlling a second closed system. The servo systemcomprises a regulation reservoir 1013 and a servo reservoir 1050. Theservo reservoir 1050 mechanically controls an implanted apparatus 10 viaa mechanical interconnection 1054. The apparatus has anexpandable/contactable cavity. This cavity is preferably expanded orcontracted by supplying hydraulic fluid from the larger adjustablereservoir 1052 in fluid connection with the apparatus 10. Alternatively,the cavity contains compressible gas, which can be compressed andexpanded under the control of the servo reservoir 1050.

The servo reservoir 1050 can also be part of the apparatus itself.

In one embodiment, the regulation reservoir is placed subcutaneous underthe patient's skin and is operated by pushing the outer surface thereofby means of a finger. This system is illustrated in FIGS. 30a-c . InFIG. 30a , a flexible subcutaneous regulation reservoir 1013 is shownconnected to a bulge shaped servo reservoir 1050 by means of a conduit1011. This bellow shaped servo reservoir 1050 is comprised in a flexibleapparatus 10. In the state shown in FIG. 30a , the servo reservoir 1050contains a minimum of fluid and most fluid is found in the regulationreservoir 1013. Due to the mechanical interconnection between the servoreservoir 1050 and the apparatus 10, the outer shape of the apparatus 10is contracted, i.e., it occupies less than its maximum volume. Thismaximum volume is shown with dashed lines in the figure.

FIG. 30b shows a state wherein a user, such as the patient in with theapparatus is implanted, presses the regulation reservoir 1013 so thatfluid contained therein is brought to flow through the conduit 1011 andinto the servo reservoir 1050, which, thanks to its bellow shape,expands longitudinally. This expansion in turn expands the apparatus 10so that it occupies its maximum volume, thereby stretching the stomachwall (not shown), which it contacts.

The regulation reservoir 1013 is preferably provided with means 1013 afor keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

An alternative embodiment of hydraulic or pneumatic operation will nowbe described with reference to FIGS. 31 and 32 a-c. The block diagramshown in FIG. 31 comprises with a first closed system controlling asecond closed system. The first system comprises a regulation reservoir1013 and a servo reservoir 1050. The servo reservoir 1050 mechanicallycontrols a larger adjustable reservoir 1052 via a mechanicalinterconnection 1054. An implanted apparatus 10 having anexpandable/contactable cavity is in nun controlled by the largeradjustable reservoir 1052 by supply of hydraulic fluid from the largeradjustable reservoir 1052 in fluid connection with the apparatus 10.

An example of this embodiment will now be described with reference toFIG. 32a-c . Like in the previous embodiment, the regulation reservoiris placed subcutaneous under the patient's skin and is operated bypushing the outer surface thereof by means of a finger. The regulationreservoir 1013 is in fluid connection with a bellow shaped servoreservoir 1050 by means of a conduit 1011. In the first closed system1013, 1011, 1050 shown in FIG. 31a , the servo reservoir 1050 contains aminimum of fluid and most fluid is found in the regulation reservoir1013.

The servo reservoir 1050 is mechanically connected to a largeradjustable reservoir 1052, in this example also having a bellow shapebut with a larger diameter than the servo reservoir 1050. The largeradjustable reservoir 1052 is in fluid connection with the apparatus 10.This means that when a user pushes the regulation reservoir 1013,thereby displacing fluid from the regulation reservoir 1013 to the servoreservoir 1050, the expansion of the servo reservoir 1050 will displacea larger volume of fluid from the larger adjustable reservoir 1052 tothe apparatus 10. In other words, in this reversed servo, a small volumein the regulation reservoir is compressed with a higher force and thiscreates a movement of a larger total area with less force per area unit.

Like in the previous embodiment described above with reference to FIGS.30a-c , the regulation reservoir 1013 is preferably provided with means1013 a for keeping its shape after compression. This means, which isschematically shown in the figure, will thus keep the apparatus 10 in astretched position also when the user releases the regulation reservoir.In this way, the regulation reservoir essentially operates as an on/offswitch for the system.

1. An apparatus for treating urinary retention of a mammal patient bydischarging urine from the urinary bladder, comprising; an implantablepowered member adapted exert a force from the outside on a selected partof the urinary bladder in order to discharge urine from the urinarybladder; and a control device for controlling the operation of thepowered member.
 2. An apparatus according to claim 1, wherein said forceis exerted at least partly against a support structure.
 3. An apparatusaccording to claim 2, wherein said support structure is adapted tosupport against at least one of, a bone, such as the pelvic bone, pubicbone or sacrum or spinal cord, other human tissue such as peritoneum,the abdominal or pelvic wall or the urine bladder itself.
 4. Anapparatus according to claim 1, wherein the control device, comprises asource of energy for operating the powered member and other energyconsuming parts of the apparatus.
 5. An apparatus according to claim 4,wherein said control device is adapted to be implanted at least partlysubcutaneously or in the abdomen or in the pelvic, region.
 6. Anapparatus according to claim 4, wherein the control device, comprises acontrol assembly adapted to be implanted both subcutaneously and in theabdominal cavity, said control assembly comprising at least two partsadapted to be connected, when implanted.
 7. An apparatus according toclaim 1, wherein the powered member comprises a contacting part (120)adapted to contact a surface part of the urinary bladder.
 8. Anapparatus according to claim 7, wherein the powered member comprises atleast one operable pressurizer (140) connected to the contacting part inan arrangement, wherein operating the pressurizer provides compressionor release of the urinary bladder.
 9. An apparatus according to claim 7,wherein the powered member is hydraulically operated to providecompression or release of the urinary bladder.
 10. An apparatusaccording to claim 7, wherein the powered member is mechanicallyoperated to provide compression or release of the urinary bladder. 11.An apparatus according to claim 8, wherein the pressurizer (140)comprises at least one movable arm (142) extending from an operationdevice (144) to the contacting part of the powered member.
 12. Anapparatus according to claim 11, wherein the operation device (144) isadapted to displace the movable arm towards the urinary bladder in orderto discharge urine from the urinary bladder.
 13. An apparatus accordingto claim 11, wherein the operation device is (144) fixated to humantissue.
 14. An apparatus according to claim 11 wherein the operationdevice is adapted for fixation to the pubic bone.
 15. An apparatusaccording to claim 11, wherein the operation device (144) comprises amotor, preferably an electric motor adapted to displace the movable arm.16. An apparatus according to claim 9, wherein the pressurizer comprisesa reservoir for hydraulic fluid, and wherein the contacting partcomprises an expandable cavity hydraulically connected to the reservoir.17. An apparatus according to claim 16, wherein the pressurizercomprises a pump for transporting the hydraulic fluid from the reservoirto expand the expandable cavity thereby compressing the urinary bladder.18. An apparatus according to claim 17, wherein the pressurizer isadapted to have the hydraulic fluid transported from the expandablecavity to the reservoir by the urinary pressure in the urinary bladder,when the pump is not active.
 19. An apparatus according to claim 12,comprising a second connection between the expandable cavity and thereservoir adapted to admit transportation hydraulic fluid from theexpandable cavity to the reservoir by the urinary pressure in theurinary bladder, when the pump is not active.
 20. An apparatus accordingto claim 19, wherein the flow capacity of the second connection issmaller than the pump flow, allowing said second connection to standopen. 21-84. (canceled)